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Integrating Depression Care in Acute Coronary Syndromes Care in China (I-Care)

Primary Purpose

Acute Coronary Syndromes, Depression

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Integrated care

About this trial

This is an interventional health services research trial for Acute Coronary Syndromes focused on measuring Health Services Research, Acute Coronary Syndromes, Depression, Integrated care

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 20 to 79 years old
Hospitalized due to a diagnosis of Acute Coronary Syndromes (ACS)
ACS is stable (as judged by the treating cardiologist/internist)
Signed patient informed consent

Exclusion Criteria:

Affected by severe cardiovascular disease or medical comorbidity that indicate the patient's life expectancy is less than 12 months (e.g. class IV heart failure, terminal cancer)
Seriously disabled (unable to travel to the hospital, class IV heart failure at baseline)
Suffering from problems that affect normal communication (e.g., intellectual impairment, observed mental confusion suggesting dementia, deafness, blindness, etc.)
Non-permanent local residents or permanent residents planning to move out within 12 months
Pregnant or breast-feeding or planning pregnancy within 12 months
Affected by bipolar disorder, schizophrenia or severe depression that meet criteria for referral including patients with acutely suicidal risk (Beck Depression Inventory Item9=3)
Having alcohol dependence (defined by MINI Alcohol Dependence/Abuse Part)

Sites / Locations

The George Institute for Global Health, China

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care (UC)

Intervention Care (IC)

Arm Description

The standard interventions from Clinical Pathway for Acute Coronary Syndromes in China-Phase 3 (CPACS-3) study that are limited to in-patient ACS care (refer to "Usual Care" [UC]), will be implemented in the participating hospitals, and hence will be received by all patients in both intervention (IC) and control (UC) groups; standardized cardiovascular disease education also will be provided to all participants.CPACS-3 registration number is NCT01398228

Besides of the UC, an nurse-coordinated integrated care model for Acute Coronary Syndromes(ACS) and depression will be delivered to intervention group, including ACS secondary prevention therapies at and after discharge, screening and treatment of depression during hospitalization and after discharge.

Outcomes

Primary Outcome Measures

Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months

Changes in mean PHQ-9 score from baseline to 12 months

Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months

Secondary Outcome Measures

Incidence of Major Adverse Cardiovascular Events (MACE)

MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease.

Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months

ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker.

Quality of life (EQ5D) at 6 and 12 months after discharge

Full Information

NCT ID

NCT02195193

First Posted

July 15, 2014

Last Updated

May 17, 2018

Sponsor

The George Institute for Global Health, China

Collaborators

National Institute of Mental Health (NIMH), Peking University Sixth Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02195193

Brief Title

Integrating Depression Care in Acute Coronary Syndromes Care in China

Acronym

I-Care

Official Title

Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

November 2014 (Actual)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The George Institute for Global Health, China

Collaborators

National Institute of Mental Health (NIMH), Peking University Sixth Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The overall goal of this study is to develop, pilot test, implement, and evaluate a nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS patients from 20 rural county hospitals selected from a well-established research network across China.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndromes, Depression

Keywords

Health Services Research, Acute Coronary Syndromes, Depression, Integrated care

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

4043 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care (UC)

Arm Type

No Intervention

Arm Description

Arm Title

Intervention Care (IC)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Integrated care

Intervention Description

an integrated care model for ACS and depression delivered by a collaborative team composed of cardiologists/internists and nurses in the same rural county hospital. The collaborative team will be able to provide medical services for the diagnosis and treatment at acute phase of ACS during hospitalization, ACS secondary prevention therapies at and after discharge, and screening and treatment of depression depressive symptom during hospitalization and after discharge. The core of the interventions includes: depressidepressive symptomon screening and classification, individual counseling and medical treatment of depression, group counseling and health education, and follow-up for ACS and depression treatments compliance, IT- system- assisting theassisted management and necessary referral.

Primary Outcome Measure Information:

Title

Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months

Description

Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months

Time Frame

Before patient discharge and after 6 months from discharge

Title

Changes in mean PHQ-9 score from baseline to 12 months

Description

Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months

Time Frame

Before patient discharge and after 12 months from discharge

Secondary Outcome Measure Information:

Title

Incidence of Major Adverse Cardiovascular Events (MACE)

Description

MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease.

Time Frame

At least 12 months after discharge

Title

Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months

Description

ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker.

Time Frame

At 6 and 12 months after discharge

Title

Quality of life (EQ5D) at 6 and 12 months after discharge

Time Frame

At 6 and 12 months after discharge

Other Pre-specified Outcome Measures:

Title

Incidence of Major Adverse Events (MACE) after discharge

Description

Includes all death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization for any reasons after discharge

Time Frame

At 6 month and 12 month after patients discharged from hospital

Title

Proportion of patients with improved cardiovascular risk surrogates

Description

Improved cardiovascular risk surrogates include blood pressure < 140/90 mmHg, heart rate < 70 beats/m, serum Low Density Lipoprotein-cholesterol < 100 mg/dL and blood sugar < 7.0 mmol/L

Time Frame

At 6 month and 12 month after discharge

Title

Proportion of patients with increased healthy life style

Description

Health life style includes physical activity >= 3 times/wk and more than 30 min. each time; no smoking, no alcohol use, and Body Mass Index (BMI) < 24 Kg/m2

Time Frame

At 6 and 12 months after discharge

Title

Proportion of patients with self-reported adherence to general medicine treatment

Description

The Morisky scale has been used to measure patients' self-reported adherence

Time Frame

At 6 and 12 months after discharge

Title

The interactions between the intervention effect on the outcomes and the modifiers

Description

Modifiers include severity of depression measured by Patient Health Questionnaire-9(PHQ-9), events within or without 6 months after discharge, age and gender

Time Frame

At 6 month or 12 month after discharge

Title

Changes in mean Mini-International Neuropsychiatric Interview (MINI) score, Enriched social support instrument(ESSI) score and Perceived social support score (PSSS) score

Description

Subsample study. 800 patients from 4 hospitals.

Time Frame

Before patient discharge and at 6,12 months after discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 20 to 79 years old Hospitalized due to a diagnosis of Acute Coronary Syndromes (ACS) ACS is stable (as judged by the treating cardiologist/internist) Signed patient informed consent Exclusion Criteria: Affected by severe cardiovascular disease or medical comorbidity that indicate the patient's life expectancy is less than 12 months (e.g. class IV heart failure, terminal cancer) Seriously disabled (unable to travel to the hospital, class IV heart failure at baseline) Suffering from problems that affect normal communication (e.g., intellectual impairment, observed mental confusion suggesting dementia, deafness, blindness, etc.) Non-permanent local residents or permanent residents planning to move out within 12 months Pregnant or breast-feeding or planning pregnancy within 12 months Affected by bipolar disorder, schizophrenia or severe depression that meet criteria for referral including patients with acutely suicidal risk (Beck Depression Inventory Item9=3) Having alcohol dependence (defined by MINI Alcohol Dependence/Abuse Part)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yangfeng Wu, MD, PhD

Organizational Affiliation

The Geogre Institute for Global Health, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

The George Institute for Global Health, China

City

Haidian

State/Province

Beijing

ZIP/Postal Code

100088

Country

China

12. IPD Sharing Statement

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Integrating Depression Care in Acute Coronary Syndromes Care in China

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